On June 3, the O&P Alliance, including AOPA’s President Charles Dankmeyer, and Executive Director Tom Fise, JD, met with the Deputy Administrator and Director of the Center for Program Integrity at CMS. The meeting included several topics: local coverage determination (LCD) recognition of O&P clinicians’ notes as part of the medical record; who can bill Medicare for prefabricated and custom-fitted orthotics and the definition of “minimal self-adjustment”; and audit concerns about new proof of delivery requirements.
The O&P Alliance requested that CMS revise certain provisions of the LCDs issued by the Durable Medical Equipment Medicare Administrative Contractors (DME MACs). Recovery auditor contractors (RACs) are restricting coverage of prosthetic care based on DME MAC instruction that “a prescription is not considered as part of the medical record” and “supplier-produced records… are not deemed part of a medical record”. Thus the medical necessity is based solely on physician documentation [typically, physicians do not receive thorough training on the specific componentry used to fabricate a custom prosthesis, so if (as CMS via its contractors has articulated) any patient record or communication to the physician by the prosthetist is automatically disqualified from consideration as biased, there is slim chance that the physician notes alone wil define medical necessity and the specific justification for each unique device to support reimbursement], resulting in denied claims on lower limb prosthetics that have been delivered. The five O&P Alliance members in a letter objected to this limited CMS view, and urged that the records from the prosthetist/orthotist’s patient care note do constitute a legitimate part of the medical record for purposes of medical necessity determinations. Consistent with that communication, during the meeting, the O&P Alliance requested that CMS and the DME MACs eliminate the restrictions on the physician’s prescription and the prosthetist’s clinical notes from being considered part of the medical record when reviewing a prosthetic limb claim for medical necessity and Medicare coverage.
The O&P Alliance also addressed the topic of determining who can provide prefabricated/custom-fabricated orthoses and prostheses. CMS asserts that orthotic fitters are not considered to have specialized training for purposes of providing custom-fitting. The O&P Alliance has taken the position, dating back to the comments the groups submitted in August, 2014 in response to CMS’ proposed rule on OTS orthotics, that CMS should continue to allow the provision of prefabricated/custom-fitted orthoses by orthotic fitters, as they have been licensed in their state or by the established accreditation bodies, provided the services are provided under the supervision of the certified orthotist (or physician, practitioner or physical/occupational therapist. Additionally, CMS has attempted to overreach with its definition of off-the-shelf orthotics by expanding the meaning of the term “minimal self-adjustment”, in contrast to Congress’s definition in BIPA 2000, Section 427. The Alliance requested that CMS regulate orthotics in a manner consistent with all federal statutory requirements, similar to the request made in a recent Congressional sign on letter to HHS Secretary Burwell.
The last topic for discussion was the DME MAC’s overreach with proof of delivery requirements, with a Jurisdiction A memo on Proof of Delivery. The memo states that HCPCS codes are not adequate for establishing proper coding determination, and instead requests a brand name or model/serial number. Congress does not have the authority to control medical device labeling, as it conflicts with the FDA’s position that most O&P devices are not obliged to carry any brand name, model or serial number. Under the new DME MAC policy, if a device which fully meets FDA labeling rules does not go beyond those rules to include the brand name, model or serial number (which FDA says is not required), they face a very high bar to meet new DME MAC requirements around the seemingly straightforward issue of what device was delivered to the Medical beneficiary, and the highly specific HCPCS code descriptor are deemed not sufficient. The O&P Alliance stressed that this new proof of delivery policy creates another administrative hurdle that would lead to more technical denials of claims, and further, the fact that it is FDA, and not CMS, that has been delegated by Congress with full control over the content of what does and does not need to be included in medical device labeling has already been decided.
While meeting with Dr. Agrawal is a productive step in correcting unfair practices targeting the O&P community, AOPA and the O&P Alliance will continue to press for tangible policy changes through meetings with CMS officials, and legislative channels including grassroots advocacy.